ENTOCORT ENEMA

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

BUDESONIDE

Available from:

TILLOTTS PHARMA GMBH

ATC code:

A07EA06

INN (International Name):

BUDESONIDE

Dosage:

2.3MG

Pharmaceutical form:

ENEMA

Composition:

BUDESONIDE 2.3MG

Administration route:

RECTAL

Units in package:

7 TABLETS, 7 SOLUTIONS

Prescription type:

Prescription

Therapeutic area:

ANTI-INFLAMMATORY AGENTS

Product summary:

Active ingredient group (AIG) number: 0116807015; AHFS:

Authorization status:

APPROVED

Authorization date:

2016-07-13

Summary of Product characteristics

_ENTOCORT_
_®_
_ ENEMA (Budesonide dispersible tablets) _
_Page 1 of 26_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ENTOCORT® ENEMA
Budesonide dispersible tablets
Enema, 0.02 mg/mL budesonide (when reconstituted), Rectal use
Glucocorticosteroid Enema
Tillotts Pharma GmbH
Warmbacher Strasse 80
79618 Rheinfelden
Germany
Date of Initial Authorization:
NOV 25, 1994
Date of Revision:
MAR 31, 2023
Importer/Distributor:
C.R.I.
Burlington, ON
L7N 3G2
Control Number: 268828
_ _
_ENTOCORT_
_®_
_ ENEMA (Budesonide dispersible tablets) _
_Page 2 of 26_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Hypersensitivity
03/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics
................................................................................................................
4
1.2
Geriatrics
................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.................................................................................
4
4.1
Dosing Considerations
............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
....................................................... 4
4.3
Reconstitution
............................................................